LAMP4yaws: Treponema pallidum, Haemophilus ducreyi loop mediated isothermal amplification − protocol for a cross-sectional, observational, diagnostic accuracy study
Michael Marks,
Tania Crucitti,
Emma Michele Harding-Esch,
Daniel Arhinful,
Earnest Njih Tabah,
Serges Tchatchouang,
Oriol Mitja,
Becca Louise Handley,
Camila González-Beiras,
Laud Antony Basing,
Kouadio Aboh Hugues,
Mohammed Bakheit,
Lisa Becherer,
Christina Ries,
Nadine Borst,
Simone Lüert,
Sieghard Frischmann,
Tamara Haerpfer,
Emelie Landmann,
Ivy Amanor,
Aboubacar Sylla,
Mireille S Kouamé-Sina,
Jean P Ndzomo-Ngono,
Adingra Tano,
Patrick Awondo,
Solange Ngazoa Kakou,
Sara Eyangoh,
Kennedy Kwasi Addo,
Sascha Knauf
Affiliations
Michael Marks
1 Faculty of Infectious and Tropical Diseases, London School of Hygiene & Tropical Medicine, London, UK
Tania Crucitti
4 Institute of Tropical Medicine, Antwerp, Belgium
Emma Michele Harding-Esch
Clinical Research Department, London School of Hygiene and Tropical Medicine Faculty of Infectious and Tropical Diseases, London, UK
Daniel Arhinful
1 Department of Epidemiology, University of Ghana, Noguchi Memorial Institute for Medical Research, Accra, Ghana
Earnest Njih Tabah
National Buruli Ulcer, Leprosy, Yaws and Leishmaniasis Control Program, Ministry of Public Health, Yaounde, Cameroon
Serges Tchatchouang
Centre Pasteur du Cameroun, Yaounde, Cameroon
Oriol Mitja
University of Barcelona, Barcelona, Spain
Becca Louise Handley
Clinical Research Department, London School of Hygiene and Tropical Medicine Faculty of Infectious and Tropical Diseases, London, UK
Camila González-Beiras
Department of Infectious Diseases, Hospital Universitari Germans Trias i Pujol, Badalona, Spain
Laud Antony Basing
University of Ghana Noguchi Memorial Institute for Medical Research, Accra, Greater Accra, Ghana
Kouadio Aboh Hugues
National Program of African Trypanosomiasis Elimination, Abidjan, Côte d`Ivoire
Mohammed Bakheit
Mast Diagnostica GmbH, Reinfeld, Germany
Lisa Becherer
IMTEK - Department of Microsystems Engineering, University of Freiburg, Freiburg im Breisgau, Germany
Christina Ries
Institute of International Animal Health/One Health, Friedrich-Loeffler-Institut, Federal Research Institute for Animal Health, Greifswald - Insel Riems, Germany
Nadine Borst
IMTEK - Department of Microsystems Engineering, University of Freiburg, Freiburg im Breisgau, Germany
Simone Lüert
Institute of International Animal Health/One Health, Friedrich-Loeffler-Institut, Federal Research Institute for Animal Health, Greifswald - Insel Riems, Germany
Sieghard Frischmann
Mast Diagnostica GmbH, Reinfeld, Germany
Tamara Haerpfer
IMTEK - Department of Microsystems Engineering, University of Freiburg, Freiburg im Breisgau, Germany
Emelie Landmann
Mast Diagnostica GmbH, Reinfeld, Germany
Ivy Amanor
University of Ghana Noguchi Memorial Institute for Medical Research, Accra, Greater Accra, Ghana
Aboubacar Sylla
Institut Pasteur de Cote d`Ivoire, Abidjan, Lagunes, Côte d`Ivoire
Mireille S Kouamé-Sina
Institut Pasteur de Cote d`Ivoire, Abidjan, Lagunes, Côte d`Ivoire
Jean P Ndzomo-Ngono
Centre Pasteur du Cameroun, Yaounde, Cameroon
Adingra Tano
Institut Pasteur de Cote d`Ivoire, Abidjan, Lagunes, Côte d`Ivoire
Patrick Awondo
Centre Pasteur du Cameroun, Yaounde, Cameroon
Solange Ngazoa Kakou
Institut Pasteur de Cote d`Ivoire, Abidjan, Lagunes, Côte d`Ivoire
Sara Eyangoh
Centre Pasteur du Cameroun, Yaounde, Cameroon
Kennedy Kwasi Addo
Noguchi Memorial Institute for Medical Research, University of Ghana, Legon, Ghana
Sascha Knauf
Institute of International Animal Health/One Health, Friedrich-Loeffler-Institut, Federal Research Institute for Animal Health, Greifswald - Insel Riems, Germany
Introduction Yaws, caused by the bacterium Treponema pallidum subsp. pertenue, is a neglected tropical disease targeted for eradication by 2030. Improved diagnostics will be essential to meet this goal. Diagnosis of yaws has relied heavily on clinical and serological tools. However, the presence of coendemic cutaneous skin ulcer diseases, such as lesions caused by Haemophilus ducreyi (HD), means these techniques do not provide a reliable diagnosis. Thus, new diagnostic tools are needed. Molecular tools such as PCR are ideal, but often expensive as they require trained technicians and laboratory facilities, which are often not available to national yaws programmes.Methods and analysis The LAMP4yaws project is a cross-sectional, observational, diagnostic accuracy study of a combined Treponema pallidum (TP) and HD loop mediated isothermal amplification (TPHD-LAMP) test performed under real world conditions in three endemic countries in West Africa. Individuals with serologically confirmed yaws will be recruited in Cameroon, Côte d’Ivoire and Ghana. Each participant will provide paired swabs, one of which will be sent to the respective national reference laboratory for yaws quantitative PCR and the other will be tested for both TP and HD using the TPHD-LAMP test at local district laboratories. Sensitivity and specificity of the TPHD-LAMP test will be calculated against the reference standard qPCR. We will also assess the acceptability, feasibility and cost-effectiveness of the test. We anticipate that results from this study will support the adoption of the TPHD-LAMP test for use in global yaws eradication efforts.Ethics and dissemination We have received ethical approval from all relevant institutional and national ethical committees. All participants, or their parents or guardians, must provide written informed consent prior to study enrolment. Study results will be published in an open access journal and disseminated with partners and the World Health Organization.Trial registration number NCT04753788.
